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Amevive

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Amevive

Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Lymphopenia

AMEVIVE® induces dose-dependent reductions in circulating CD4+ and CD8+ T lymphocyte counts. CD4+ counts should be normal before initiating treatment with AMEVIVE® and should be closely monitored during AMEVIVE® treatment [see DOSAGE AND ADMINISTRATION]

Malignancies

AMEVIVE® may increase the risk of malignancies. Malignancies were reported in subjects who received AMEVIVE® in clinical studies [see ADVERSE REACTIONS].

In preclinical studies, animals developed B cell hyperplasia, and one animal developed a lymphoma [see Nonclinical Toxicology]. AMEVIVE® should not be administered to patients with a history of systemic malignancy.

Exercise caution when considering the use of AMEVIVE® in patients at high risk for malignancy. Discontinue AMEVIVE® if a patient develops a malignancy.

Serious Infections

AMEVIVE® is an immunosuppressive agent and, therefore, has the potential to increase the risk of infection and reactivate latent, chronic infections. Serious infections (infections requiring hospitalization) were reported in subjects who received AMEVIVE® [see ADVERSE REACTIONS]. AMEVIVE® should not be administered to patients with a clinically important infection. Exercise caution when considering the use of AMEVIVE® in patients with chronic infections or a history of recurrent infection. Patients should be monitored for signs and symptoms of infection during or after a course of AMEVIVE®. New infections should be closely monitored. If a patient develops a serious infection, AMEVIVE® should be discontinued [see ADVERSE REACTIONS].

Concomitant Therapies

Patients receiving other immunosuppressive agents or phototherapy should not receive concurrent therapy with AMEVIVE® because of the possibility of excessive immunosuppression.

Immunizations

The safety and efficacy of live or live-attenuated vaccines in patients being treated with AMEVIVE® have not been studied. In a study of 46 patients with chronic plaque psoriasis, the ability to mount immunity to tetanus toxoid (recall antigen) and an experimental neo-antigen was preserved in those patients undergoing AMEVIVE® therapy.

Hypersensitivity Reactions

Urticaria and angioedema have been associated with the administration of AMEVIVE®. If an anaphylactic reaction or other serious allergic reaction occurs, discontinue AMEVIVE® immediately and initiate appropriate therapy.

Hepatic Injury

In post-marketing experience there have been reports of liver injury, including asymptomatic transaminase elevation, fatty infiltration of the liver, hepatitis, decompensation of cirrhosis with liver failure, and acute liver failure. Liver failure has been reported with concomitant alcohol use [see ADVERSE REACTIONS].

In the 24-week period constituting the first course of placebo-controlled studies, 1.7% (15/876) of AMEVIVE®-treated patients and 1.2% (5/413) of the placebo group experienced ALT and/or AST elevations of at least 3 times the upper limit of normal. While the exact relationship of these occurrences with the use of AMEVIVE®has not been established, patients with signs or symptoms of liver injury should be fully evaluated. AMEVIVE® should be discontinued in patients who develop clinical signs of liver injury.

Patient Counseling Information

"See FDA-approved patient labeling (Medication Guide)"

Inform patients of the need for regular monitoring of white blood cell (lymphocyte) counts during therapy with AMEVIVE®. Inform patients that the reduction in lymphocytes could increase their chances of developing an infection or a malignancy. Advise patients to inform their physician promptly if they develop any signs of an infection or malignancy while undergoing a course of treatment with AMEVIVE®.

Advise female patients to notify their physicians if they become pregnant while taking AMEVIVE® or within 8 weeks of discontinuing AMEVIVE®.

Inform patients that serious liver injury has been reported in patients receiving AMEVIVE®. Patients should be advised to report to their physician persistent nausea, anorexia, fatigue, vomiting, abdominal pain, jaundice, easy bruising, dark urine or pale stools.

Inform patients that hypersensitivity reactions have been reported in patients receiving AMEVIVE®. Patients should promptly notify their physicians should urticaria or signs of angioedema (e.g. facial edema) develop.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a chronic toxicity study, cynomolgus monkeys were dosed weekly for 52 weeks with intravenous alefacept at 1 mg/kg/dose or 20 mg/kg/dose. One animal in the high dose group developed a B-cell lymphoma that was detected after 28 weeks of dosing. Additional animals in both dose groups developed B-cell hyperplasia of the spleen and lymph nodes. One-year post-treatment there was no evidence of alefacept-related lymphoma or B-cell hyperplasia in any of the remaining treated monkeys.

All animals in the study were positive for an endemic primate gammaherpes virus also known as lymphocryptovirus (LCV). Latent LCV infection is generally asymptomatic, but can lead to B-cell lymphomas when animals are immune suppressed.

In a separate study, baboons given 3 doses of alefacept at 1 mg/kg every 8 weeks were found to have centroblast proliferation in B-cell dependent areas in the germinal centers of the spleen following a 116-day washout period.

The role of AMEVIVE® in the development of the lymphoid malignancy and the hyperplasia observed in non-human primates and the relevance to humans is unknown. Immunodeficiency-associated lymphocyte disorders (plasmacytic hyperplasia, polymorphic proliferation, and B-cell lymphomas) occur in patients who have congenital or acquired immunodeficiencies including those resulting from immunosuppressive therapy.

No formal carcinogenicity or fertility studies were conducted.

Mutagenicity studies were conducted in vitro and in vivo; no evidence of mutagenicity was observed.

Use In Specific Populations

Pregnancy

Pregnancy Category B

There are no adequate and well-controlled studies of AMEVIVE® in pregnant women. AMEVIVE® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Reproductive toxicology studies have been performed in cynomolgus monkeys at doses up to 5 mg/kg/week (about 62 times the human dose based on body weight) and have revealed no evidence of impaired fertility or harm to the fetus due to AMEVIVE®. No abortifacient or teratogenic effects were observed in cynomolgus monkeys following intravenous bolus injections of AMEVIVE® administered weekly during the period of organogenesis to gestation. AMEVIVE® underwent trans-placental passage and produced in utero exposure in the developing monkeys. In utero, serum levels of exposure in these monkeys were 23% of maternal serum levels. No evidence of fetal toxicity including adverse effects on immune system development was observed in any of these animals.

Nursing Mothers

It is not known whether AMEVIVE® is excreted in human milk. Because many drugs are excreted in human milk, and because there exists the potential for serious adverse reactions in nursing infants from AMEVIVE®, a decision should be made whether to discontinue nursing while taking the drug or to discontinue the use of the drug, taking into account the importance of the drug to the mother.

Pediatric Use

The safety and efficacy of AMEVIVE® in pediatric patients have not been studied. AMEVIVE® is not indicated for pediatric patients.

Geriatric Use

Of the 1869 patients who received AMEVIVE® in clinical trials, a total of 129 patients were ≥ 65 years of age and 16 patients were ≥ 75 years of age. No differences in safety or efficacy were observed between older and younger patients, but there were not sufficient data to exclude important differences. Because the incidence of infections and certain malignancies is higher in the elderly population, in general, caution should be used in treating the elderly.

Last reviewed on RxList: 6/8/2012
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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